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Assessing Cosopt Switch Patients

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ClinicalTrials.gov Identifier: NCT00273442
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : November 19, 2008
Sponsor:
Information provided by:
Pharmaceutical Research Network

Study Description
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Brief Summary:
To assess the safety and efficacy of a cohort of patients switched to the dorzolamide/timolol maleate fixed combination because they are insufficiently controlled on latanoprost monotherapy.

Condition or disease Intervention/treatment Phase
Ocular Hypertension Open-Angle Glaucoma Exfoliation Syndrome Glaucoma, Pigmentary Drug: timolol maleate Drug: dorzolamide/timolol maleate fixed combination Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2005
Actual Study Completion Date : April 2007

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults with clinical diagnosis of POAG, pigment-dispersion or exfoliation glaucoma or ocular hypertension
  • the IOP on latanoprost must be 31 mm Hg or less in both eyes, and 21 to 31 mm Hg inclusive in at least one eye at 08:00 AM
  • visual acuity should be 20/200 or better in each eye

Exclusion Criteria:

  • contraindications to study drugs
  • anticipated change in systemic hypotensive therapy during the trial
  • use of any corticosteroids by any route in the three months immediately prior to Visit 2
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00273442


Locations
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United States, Arkansas
Little Rock Eye Clinic
Little Rock, Arkansas, United States, 72205
United States, Georgia
Omni Eye Services
Atlanta, Georgia, United States, 30342
United States, Illinois
Midwest Eye Center
Bourbonnais, Illinois, United States, 60914
United States, Oklahoma
Mark J. Weiss, MD
Tulsa, Oklahoma, United States, 74104
United States, South Carolina
Glaucoma Consultants & Center for Eye Research
Mt. Pleasant, South Carolina, United States, 29464
Sponsors and Collaborators
Pharmaceutical Research Network
Investigators
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Study Director: William C. Stewart, MD Pharmaceutical Research Network, LLC
Principal Investigator: Mark J. Weiss, MD
Principal Investigator: Douglas G. Day, MD Omni Eye Services
Principal Investigator: Sriram Sonty, MD, FACS Midwest Eye Center
Principal Investigator: J. Charles Henry, MD Little Rock Eye Clinic
Principal Investigator: Elizabeth D. Sharpe, MD Glaucoma Consultants & Center for Eye Research
More Information
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ClinicalTrials.gov Identifier: NCT00273442     History of Changes
Other Study ID Numbers: PRN 05-007
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: November 19, 2008
Last Verified: November 2008
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Exfoliation Syndrome
Eye Diseases
Iris Diseases
Uveal Diseases
Timolol
Dorzolamide
Maleic acid
 Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Enzyme Inhibitors
Carbonic Anhydrase Inhibitors